FiberVision
by Fiber Imaging, Inc. 510(k)
Active
510(k) K895733
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895733 | Date21 Nov 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Fibervision(Tm)
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The FiberVision is a linear medical accelerator, designed for precise radiation therapy delivery in radiology settings. It utilizes advanced fiber-optic technology to enhance imaging and treatment accuracy during procedures such as brachytherapy or external beam radiotherapy.
This device is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as radiation oncology departments. It operates under FDA 510(k) clearance (K895733) and adheres to regulatory standards outlined in 892.5050. The device is classified as Class II under the FDA’s device classification system and is intended for professional medical use only.
Questions
AI-generated answers, 19 Sep 2026
What types of radiation therapy procedures is the FiberVision designed to support in clinical settings?
The FiberVision is specifically designed for precise radiation therapy delivery in procedures such as brachytherapy and external beam radiotherapy. Its advanced fiber-optic technology enhances imaging and treatment accuracy, making it suitable for controlled environments like radiation oncology departments.
Is the FiberVision intended for single-use or reusable applications, and how does this impact its maintenance?
The FiberVision is supplied as a reusable medical instrument, meaning it is engineered for repeated use in clinical settings. As a reusable device, it requires adherence to strict cleaning, sterilization, and maintenance protocols to ensure safety and performance consistency between procedures.
What regulatory pathway was followed for the FiberVision’s FDA clearance, and which advisory committee was involved?
The FiberVision received FDA clearance through a Traditional 510(k) pathway, classified as Substantially Equivalent (SESE) to a predicate device. The review was conducted by the Radiology (RA) Advisory Committee, aligning with its intended use in radiology settings for radiation therapy delivery.
How many distinct models or configurations of the FiberVision are available, and are they interchangeable?
The FiberVision is associated with multiple FEI registration numbers (e.g., 3013410552, 3003768277, etc.), which may correspond to different models or configurations. However, interchangeability between these models is not explicitly stated in the provided data, so compatibility should be verified with the manufacturer before use.